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临床试验/NCT03836183
NCT03836183已完成不适用

Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery

Association Pro-arte2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.

研究概览

简要总结

Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm.

Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost.

The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.

详细描述

In thoracic surgery, it is common to use selective intubation probes to exclude from ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy which is the reference examination to confirm the good position of these probes. The interest of systematically controlling the good position of the left selective intubation probe by fibroscopy is controversial.

The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and atelectasis.

The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several teams used it to ensure proper endotracheal tube positioning and to diagnose selective intubation. In fact, it has been shown that to control the position of the probe more precisely, ultrasound is more efficient than auscultation.

The aim of this work is to show by a large-scale prospective study that pleuropulmonary ultrasound associated with the clinical examination confirms the exclusion of the operated lung. the absence of systematic control of the positioning of the probe by fibroscopy allow financial gain and a reduction in the risk of morbidity related to the realization of this invasive gesture.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient will benefit from thoracic or cardiac surgery requiring selective left intubation.
  • Affiliation to the French social security

排除标准

  • Minor patients
  • Refusal of the patient
  • Patients under guardianship, curators.
  • Surgery not compatible with a visualization of the pleural slip in echography: surgery of pneumothorax or liquid effusion
  • History likely to disturb the detection of pleural slip on ultrasound: pneumothorax surgery
  • Predictable intubation difficulties and the need for selective bronchial blocker intubation
  • Pregnant or lactating women

结局指标

主要结局

To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.

时间窗: During peroperative period

The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures \< 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.

次要结局

  • to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.(During peroperative period)
  • To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.(at the end of the inclusion period, an average of 1 year)
  • Assess the surgeon's satisfaction with lung exclusion: visual analogue scale(at the end of the surgery, day 1)
  • determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.(During ultrasound)

研究者

发起方
Association Pro-arte
申办方类型
Other
责任方
Sponsor

研究点 (2)

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